‘Innovation Passport’ Necessary For UK Project Orbis Reviews
MHRA Specifies Prerequisites For International Oncology Drug Review Initiative
Promising cancer medicines will need to be included in the UK’s new licensing pathway for innovative drugs before the UK medicines regulator will agree to their review under the Project Orbis initiative.
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Experience gained from pilot participation has convinced the Swiss medicines agency that the collaborative cancer drug review initiative is the way forward.
A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.
Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.